Kornimate/medical-research-clean huggingface dataset:
adjunctive bright light therapy in patients with bipolar depression and eveningness

Conditions: Bipolar Depression

Summary: this is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.

this randomized placebo-controlled trial aims to evaluate the efficacy of adjunctive blt in addition to their maintenance treatment in reducing depressive symptoms. the second aim of the study is to explore the effects of blt on sleep-wake changes and the sleep disturbances. method: each eligible participant will be randomized to either i) bright light therapy (blt) or ii) inactive negative ion generator (placebo) treatment for 30-minutes daily at their habitual wake time for a total of six weeks. participants will be evaluated at baseline, 2nd, 4th and 6th week for depression and insomnia symptoms. actigraphy will be done at baseline and in the last week of treatment.

Eligibility criteria:
inclusion criteria: 1. aged 18-65 years. 2. is capable to give informed consent. 3. meeting the diagnostic criteria of bipolar depression (including both bipolar i and ii disorders) by the structured clinical interview for diagnostic and statistical manual of mental disorders, 5th edition (dsm-v), disorders (scid-v). 4. a score 20 or above representing current moderate or severe episode of major depression and a score of at least 1 on items h1 or h2 on the structured interview guide for the hamilton depression rating scale with atypical depression supplement (sigh-ads), corresponding to at least moderate severity. 5. a score of 41 or less by the morningness-eveningness questionnaire which represents eveningness. 6. on a stable dose of antimanic treatment for bipolar disorder for at least four weeks. exclusion criteria: 1. major depressive disorder fulfilling the seasonal pattern specifier of the dsm-v (seasonal affective disorder). 2. a past history of rapid-cycling within the past twelve months or a young mania rating scale more than 12 at screening 3. a current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder. 4. presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments. 5. presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications such as st. john's wart; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma, and photosensitive skin condition e.g. systemic lupus erythematosus 6. significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview. 7. regular shift-workers or trans-meridian flight in the past 3 months or during study 8. enrolment in another clinical trial of an investigational medicinal product or device. 9. receiving regular psychotherapy.

Keywords: bipolar depression eveningness bright light therapy
endometrial biopsy prior to ivf in those patients with prior implantation failure

Conditions: Implantation Failure; Infertility

Summary: this proposed research is a single center, prospective, single-blinded, randomized controlled trial, designed to evaluate ivf pregnancy outcomes following endometrial injury in 254 patients with implantation failure. patients will be identified during their work-up and treatment at shady grove fertility reproductive science center. only shady grove patients are eligible for the study. the investigators hypothesize in patients with one or more previous failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will improve clinical pregnancy outcomes compared to controls.

despite advances in assisted reproductive technologies; implantation failure in patients undergoing in-vitro fertilization (ivf) is frequent. unfortunately, few treatments exist except for the use of a gestational carrier. there have been a number of recent clinical studies demonstrating that local injury to the endometrium results in improved clinical pregnancy outcomes for patients with a history of implantation failure. however, not all studies have shown a beneficial effect, and those demonstrating benefit have been limited by small sample sizes, and considerable heterogeneity in the procedures and populations evaluated. a recent meta-analysis synthesized the available data concluded that a large, prospective, well-designed randomized trial is desperately needed to definitively assess this new possible treatment. if these preliminary findings from previous trials are confirmed, this practice could be applied in the clinical setting to help patients suffering from repeated implantation failures.

Eligibility criteria:
inclusion criteria: * women age 18-37 * one or more previous implantation failures with autologous fresh or frozen blastocyst transfer * undergoing fresh autologous ivf cycle * no other current uterine (i.e.: uterine fibroids, polyps), hematologic, or genetic causes for infertility and implantation failure * one or more good quality blastocyst(s) available for transfer exclusion criteria: * those unable to comprehend the investigational nature of the proposed study * positive pregnancy test * possible causes for impaired implantation (systemic disease, endometriosis, ultrasound evidence of current hydrosalpinx, uterine polyps, uterine myomas (fibroids), uterine cavity malformations or asherman's syndrome) * poor responders, defined as fsh \>12 on day 3 or less than 4 follicles on a previous ivf cycle * bmi \>30 or \<18

Keywords: implantation failure in-vitro fertilization infertility endometrial biopsy
the effect of pharmacist intervention on the use of zostavax in a community pharmacy setting

Conditions: Herpes Zoster

Summary: the purpose of this study is to determine whether pharmacist-driven patient interventions can have an effect on the number of herpes zoster (zostavax) vaccinations given in a community pharmacy setting.

several studies exist documenting the perception and satisfaction of patients receiving immunizations from pharmacists, as well as the effects of pharmacist involvement in advocating and administering vaccinations. the most well documented studies have been conducted in hospital settings. undoubtedly, there is enormous opportunity for the community pharmacist to identify potential vaccine recipients, advocate immunization and administer said immunizations to their established patient populations. however, there is a lack of concentrated study in the implementation of immunization services in the community setting and their effects. the investigators intend to evaluate the intervention of pharmacists in an immunization program and the resulting changes in immunization rates.

Eligibility criteria:
inclusion criteria: * men and women aged 60 or older without contraindications for the herpes zoster vaccination * patients who have already experienced one or more episodes of herpes zoster infection were considered for vaccine receipt and study inclusion secondary to cdc acip recommendations exclusion criteria: * patients aged \< 60 years * anyone who has previously received the herpes zoster vaccine * anyone with an allergy to neomycin, gelatin or any other component of the vaccine * anyone receiving a live vaccine within 4 weeks * anyone with a compromised or weakened immune systems such as those receiving radiation, corticosteroids, or those with hiv/aids, cancer in the lymph, bone or blood systems * pregnant women or those in close contact with a pregnant woman

Keywords: herpes zoster prevention & control pharmacists pharmacy pharmacies aged immunization vaccination
the relationship between osteoporosis and chronic oral anticoagulation therapy with warfarin

Conditions: Osteoporosis

Summary: the purpose of this study is to determine if osteoporosis is an unrecognized complication of chronic anticoagulation with warfarin.


Eligibility criteria:
inclusion criteria: * patients on warfarin that have had bmd within a year exclusion criteria: * patients on bisphosphates, serms, anticonvulsants, estrogens, androgens, calcitonin, hctz and thyroid hormone replacement

Keywords: warfarin use
evaluation of daptomycin for the emergency department treatment of complicated skin and skin structure infections

Conditions: Cellulitis; Skin Infections

Summary: this is a prospective, randomized clinical trial comparing daptomycin to vancomycin in the emergency department (ed) treatment of complicated skin and skin structure infection in the rapid diagnosis and treatment center (rdtc). in brief, a convenience sample of patients who are admitted to the rdtc cellulitis protocol in the ed will be randomized to either vancomycin, which is currently an accepted care standard in the rdtc cellulitis protocol, or daptomycin, which is the experimental treatment in this study. the primary hypothesis is that daptomycin treatment is as efficacious as standard therapy in the treatment of ed cellulitis.

specific aim 1: compare the efficacy of daptomycin to the efficacy of vancomycin for the treatment of complicated skin and skin structure infection in the ed. patients eligible for the rdtc cellulitis treatment protocol will be screened for inclusion in the study. after informed consent, patients will be randomized to receive either daptomycin or vancomycin (1:1 ratio). a case report form (crf) detailing medical history, clinical characteristics, and treatments will be completed. the patients will be evaluated for meeting rdtc discharge criteria. the following time points will be collected: 1. actual time patient meets discharge criteria based on the rdtc cellulitis protocol; 2. time of disposition defined as the time treating physician writes discharge orders; and, 3. time the patient actually leaves the emergency department. subsequently, the patient will be followed up by telephone to ascertain whether a change in antibiotic therapy or a return ed visit for complicated skin and skin structure infection occurred within 30 days of the initial rdtc enrollment specific aim 2: compare the change in area and erythema of the cellulitic lesion between patients treated with daptomycin and patients treated with vancomycin. patients enrolled in the study will have serial digital photographs of their primary lesion taken. the images will be processed blinded to clinical data and asynchronous to the ed stay. the change in lesion area and erythema will be calculated.

Eligibility criteria:
inclusion criteria: * admitted to rdtc to the cellulitis protocol * 18 yrs old or greater * able and willing to give informed consent * hemodynamically stable (systolic blood pressure \>90mmhg and heart rate \<120 beats per minute) exclusion criteria: * antibiotics given prior to enrollment * suspected necrotizing infection * diabetic foot ulcer * genitourinary involvement * post operative infection (not including simple wound closure infection) * suspected gouty or septic arthritis * chronic lymphangitis * requiring routine hemodialysis * patient reported allergy to vancomycin * patient reported allergy to daptomycin * participation in another investigational treatment study within 30 days prior to enrollment * prisoner * pregnant or breast-feeding * complicated skin and skin structure infection of the face
immune correlates of cardiac structure and function

Conditions: Perinatal HIV Infection; Cardiac Fibrosis; Cardiac Inflammation

Summary: the purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired human immunodeficiency virus (hiv) infection compared to people not infected with hiv. the information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired hiv infection compared to the uninfected. participants will have a blood sample, complete a patient questionnaire, and have a magnetic resonance imaging (mri) and ultrasound of the heart. researchers will review the medical record and past medical history, for information about your heart function and overall health. research samples and data from this study will be stored indefinitely and used for other research. there are risks to participate in this study and those risks include side effects from the contrast agent used for the mri scan, (such as headache and injection site pain), and risks from blood sampling.


Eligibility criteria:
inclusion criteria: 1. individuals 20-45 years of age 2. willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures 3. diagnosed with hiv \<10 years of age or physician confirmation of perinatal hiv infection 4. on antiretroviral treatment (art) for at least the last greater than or equal to 6 months 5. willingness to undergo cardiovascular magnetic resonance imaging (cmr) 6. willingness to undergo echocardiogram (echo) (may be included if echo has been done at duke in the previous 24 months). 7. willingness to have research blood draw exclusion criteria: 1. contraindication to cmr (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips) 2. estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 3. history of anaphylactic reaction to gadolinium contrast 4. inability to complete an mri scan in the past due to anxiety 5. recent acute medical illness resulting in recent hospitalization (in past 90 days) 6. history of: coronary artery disease (cad), myocardial infarction (mi), moderate-severe valvular disease, congenital heart disease, heart failure, non-ischemic cm, atrial fibrillation/flutter, implantable cardioverter defibrillator (icd)/pacemaker, myocarditis prior 7. current symptoms of shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs 8. known to be pregnant or current breastfeeding 9. known to be on hemodialysis 10. inability to breath hold for 5-10 seconds 11. known to have an ejection fraction \<45% in the past 24 months 12. active cancer or cancer chemotherapy or radiation treatment in the prior year. 13. comorbid inflammatory disease, specifically treated for rheumatoid arthritis (ra) or lupus (sle) 14. chronic use of steroids or anti-inflammatory therapy
evaluate the safety and effectiveness of steerable ureteroscopic renal evacuation (sure) using the cvac® system

Conditions: Renal Stones; Kidney Stone; Urolithiasis

Summary: the purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the cvac system for the treatment of urinary stones.


Eligibility criteria:
inclusion criteria: * candidate for ureteroscopy with laser lithotripsy; * be willing and able to return for and respond to all study-related follow up procedures; and, * have been informed of the nature of the study and have agreed to the irb approved informed consent form (icf). exclusion criteria: * significant morbidities; * unable to meet the treatment and follow up protocol requirements; and, * ureteral or kidney abnormalities.
impact of sensory re-education paradigm on sensation and quality of life in patients post-covid 19 polyneuropathy

Conditions: Post-COVID-19 Syndrome

Summary: this study will be conducted to investigate the effect of a sensory re-education paradigm on sensation and proprioception in patients with post covid-19 neuropathy.

the coronavirus disease has profoundly impacted the world, altering the functioning of the population and health system. it is so far affected more than 532 million cases and 6.3 million confirmed deaths (who., 2020). recent studies documented that covid-19-associated peripheral neuropathy is a common and frequent problem, with neuro-muscular complications. this phenomenon is widespread in those with comorbidities, such as diabetes mellitus, which may result from immune processes or as side effects of some medications used to manage covid-19 symptoms, such as hydroxychloroquine, clindamycin, and steroids. to a lesser extent, prolonged hospitalization may cause entrapment neuropathy (peripheral nerve compression). most physiotherapists focus on motor improvements rather than sensibility improvements though the sensory system may have the upper hand in improving motor function. therefore; the sensory re-education paradigm should be assessed in randomized trials with a blinded assessment of functional outcomes to evaluate its effectiveness in patients with post covid-19 neuropathic patients. currently, there is not enough research addressing the impact of the sensory re-education paradigm on sensation and quality of life in neuropathic patients post-covid19. forty patients will be assigned randomly into two equal groups; the study group will receive sensory re-education paradigm and traditional treatment while the control group will receive traditional treatment only.

Eligibility criteria:
inclusion criteria: patients from both genders (male and female). the age of participants ranged from 30 to 40 years old. participants were required to live in egypt during the pre-covid and covid-19 pandemic. patients with confirmation of previous covid19 infection pcr test. patients meeting the guide line of world health organization (who) of long/post-covid 19 syndromes. patients with unknown prior neuropathy. patients with neuropathy confirmed by edx with a sensory nerve conduction velocity. exclusion criteria: patients with diabetes mellitus (dm), rheumatology and guillain-barré syndrome (gbs). infection other than covid19 leading to sensory neuropathy. traumatic or compressive lesions leading to central nervous system (cns), peripheral nervous system (pns) damages. previous surgeries or medications leading to neuropathy.

Keywords: post-covid 19 polyneuropathy sensory re-education paradigm sensation quality of life
study of the response to a neoadjuvant chemotherapy based on the antitumor immune response in localized breast cancer

Conditions: Breast Cancer

Summary: this is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer. 40 patients will be enrolled in the study. they will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 fec-100 cycles followed by 3 or 4 taxane cycles. trastuzumab will be added to taxane for her2+/neu+ patients. then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation. blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse. tumor sample will be collected on diagnosis as much as possible and on surgery. patients will be followed during 5 years.


Eligibility criteria:
inclusion criteria: * histologically proven localized breast cancer required anthracycline chemotherapy +/- trastuzumab before surgery * age \> 18 years * chemotherapy with 3 anthracycline cycles to begin (doxorubicin or epirubicin) * any previous treatment for this cancer * performance status \<= 1 * agreement for the conservation of biological samples * covered by an medical insurance * signed written informed consent form * availability of tumoral sample collected at diagnosis exclusion criteria: * previous surgery for the breast cancer * already under chemotherapy before the first blood sample * previous antitumoral treatment * under immunosuppressive treatment * under corticoids during the 15 days before enrollment * history of concomitant cancer except if it has been cured for at least 5 years * history of lymphoma or breast sarcoma * history of chronic inflammatory disease or autoimmune disease, hepatitis b or c or immune dysfunction disease (including hiv-positive stage aids) known * history of other disease which is discrepant with this study * deprived of liberty by court or administrative decision * pregnant or breastfeeding women or with no use of effective birth control methods for women of childbearing potential

Keywords: anti-tumor immune response neo-adjuvant chemotherapy relapse long term survival histo-pathological response tumor cell death tumor associated antigens calreticulin localized breast cancer
examination of clinical and laboratory abnormalities in patients with defective dna repair: xeroderma pigmentosum, cockayne syndrome, or trichothiodystrophy

Conditions: Cockayne Syndrome; Skin Neoplasms; Xeroderma Pigmentosum; Trichothiodystrophy Syndromes; Genodermatosis

Summary: four rare genetic diseases, xeroderma pigmentosum (xp), cockayne syndrome (cs), the xp/cs complex and trichothiodystrophy (ttd) have defective dna excision repair although only xp has increased cancer susceptibility. we plan to perform careful clinical examination of selected patients with xp, xp/cs, cs, or ttd and follow their clinical course. we will obtain tissue (skin, blood, hair, buccal swabs) for laboratory examination of dna repair and for genetic analysis. we hope to be able to correlate these laboratory abnormalities with the clinical features to better understand the mechanism of cancer prevention by dna repair. patients will be offered counseling and education for cancer control.

three rare genetic diseases, xeroderma pigmentosum (xp), cockayne syndrome (cs), and trichothiodystrophy (ttd) have defective dna excision repair although only xp has increased cancer susceptibility. we plan to perform careful clinical examination of selected patients with xp, cs, ttd, or overlap syndromes to follow their clinical course. we will obtain tissue (skin, blood, hair, or buccal cells) for laboratory examination of dna repair and for histologic, protein, biochemical, and genetic analysis. we hope to be able to correlate these laboratory abnormalities with the clinical features to better understand the mechanism of cancer prevention by dna repair. patients will be offered counseling and education for cancer control.

Eligibility criteria:
* inclusion criteria: * subjects age 6 weeks and above: * with clinical and/or laboratory documentation of typical features or suggestive clinical features of xp, cs, ttd, or overlap syndromes or * that are first degree relatives or other family members of participants with xp, cs, ttd, or overlap syndromes * healthy volunteers of age 1 year and above (including nih employees) willing to donate blood, skin, buccal cells, or hair. * patients or legally authorized representatives must provide informed consent. exclusion criteria: -inability or unwillingness to provide tissue (skin, blood, buccal cells or hair) for laboratory studies.

Keywords: xeroderma pigmentosum trichothiodystrophy cockayne syndrome skin cancer dna repair natural history